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The revised Guideline is intended to provide updated advice for applicants concerning the information to be included in the core Summary of Product Characteristics ("SmPC") for industrially manufactured plasma-derived fibrin sealant/haemostatic products. In accordance with Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004, a SmPC must be included in an application or a marketing authorisation. In addition, the SmPC must comply with the requirement provided in Article 11 of Directive 2001/83/EC.

Medicinal products used with pressurized gas fibrin sprayers

According to the revised Guideline, statements on medicinal products used with pressurised gas fibrin sprayers must be added to the core SmPC. Precautionary measures governing the disposal and handling of spray applications are laid down in Section 6.6 of the revised Guideline.

Where applicable, an applicant must provide the instructions below in relation to products recommended for use with pressurised gas fibrin sprayers where no air gas embolism cases have been reported:

"To avoid the risk of potentially life-threatening air or gas embolism (Invented) name of the product} is recommended to be sprayed using pressurised CO2".

In cases where air or gas embolism conditions have been reported or a known risk has been identified, the statement below must be included in the core SmPC:

"To avoid the risk of potentially life-threatening air or gas embolism {(Invented) name of the product} should be sprayed using pressurised CO2 gas only (see table below)".

As outlined in the revised Guideline, information concerning safety precautions must be developed in accordance with the table provided in Section 6.6 of the Guideline. Application of the product using a spray device must be within recommended ranges and instructions must be provided under the following headings:

Surgery;

Spray to be used;

Applicator tips to be used;

Pressure regulator to be used;

Recommended distance from target tissue; and

Recommended spray pressure.

Further instructions are included in the core SmPC to ensure that precautionary measures are observed during the application of products using a spray device.

The requirement to format the SmPC for industrially manufactured plasma-derived fibrin sealant/haemostatic products in compliance with the revised Guideline will come into effect on 1 January 2016.